FDA Device recall Z-1459-2021
BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product Usage: intended to provide ventricular tachycardia pac…
- FDA Device
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product Usage: intended to provide ventricular tachycardia pac… by Biotronik, citing there is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1459-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-08 |
| Published | 2021-04-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biotronik |
| Distribution | US |
Product
BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Reason
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Identifiers
| code_info | Serial Number 60934351 60829152 60832096 60832371 60832379 60832390 60832402 60832413 60832416 60832741 6083…Serial Number 60934351 60829152 60832096 60832371 60832379 60832390 60832402 60832413 60832416 60832741 60832748 60832754 60832761 60832763 60832880 60832889 60832910 60832928 60834412 60834435 60836055 60836063 60837602 60839079 60839092 60839097 60851001 60852519 60852527 60853576 60853580 60854501 60855490 60855495 60855499 60857084 60857085 60857086 60857087 60857103 60857710 60857718 60857721 60857789 60858453 60858457 60858460 60858466 60858468 60858472 60858477 60858480 60858481 60858483 60859370 60859372 60859378 60859380 60859388 60859392 60859395 60859409 60859413 60859417 60860802 60860804 60860808 60861046 60861047 60861052 60861176 60861177 60861179 60861180 60861182 60861188 60861191 60861242 60861243 60861247 60861248 60861252 60861259 60861271 60861289 60861290 60861292 60861294 60861297 60861298 60861299 60861300 60861303 60861323 60861326 60861329 60861330 60861337 60861 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1459-2021%22
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